Squalamine
Encyclopedia
Squalamine is a strong naturally derived broad-spectrum antibiotic
that is predominantly derived from the livers of dogfish
and other shark species. Squalamine is sometimes confused with the similar sounding squalene
, an unrelated compound also found in shark-liver.
function – that is, it inhibits the growth of blood vessels. Because of this function, squalamine in its intravenous form, squalamine lactate, is in the process of being tested as a treatment of fibrodysplasia ossificans progressiva
, a rare disease where connective tissue
will ossify when damaged. Squalamine is also undergoing trials for treatment of non-small cell lung cancer
(stage I/IIA) as well as general phase I pharmacokinetic studies. In 2005, the Food and Drug Administration
granted squalamine Fast Track status for approval for treatment of age-related macular degeneration
. However, the Genaera Corporation, the company that has done the most work with squalamine, discontinued trials for its use in treating prostate cancer
and wet age-related macular degeneration
in 2007.
The Squalamine project was acquired by Ohr Pharmaceutical from the now liquidated Genaera, with the prospect of continuing the development of this drug to treat wet age-related macular degeneration
.
A company (Nu-Gen Nutrition, Inc.) markets a product called 'Squalamax' as a dietary supplement
, which it claims has concentrated Squalamine. The product has not been approved as a drug and cannot make therapeutic claims, as noted by the FDA in a Warning Letter
.
s. First synthesized in 1995, squalamine is usually artificially sourced.
Broad-spectrum antibiotic
The term broad-spectrum antibiotic refers to an antibiotic that acts against a wide range of disease-causing bacteria. A broad-spectrum antibiotic acts against both Gram-positive and Gram-negative bacteria, in contrast to a narrow-spectrum antibiotic, which is effective against specific families of...
that is predominantly derived from the livers of dogfish
Squaliformes
Squaliformes is an order of sharks that includes about 97 species in seven families.Members of the order have two dorsal fins, which usually possess spines, no anal fin or nictitating membrane, and five gill slits. In most other respects, however, they are quite variable in form and size...
and other shark species. Squalamine is sometimes confused with the similar sounding squalene
Squalene
Squalene is a natural organic compound originally obtained for commercial purposes primarily from shark liver oil, though plant sources are used as well, including amaranth seed, rice bran, wheat germ, and olives. All plants and animals produce squalene, including humans...
, an unrelated compound also found in shark-liver.
Pharmacology
While used first as an effective broad-spectrum antibiotic, it has been found recently that it can perform a powerful anti-angiogenesisAngiogenesis
Angiogenesis is the physiological process involving the growth of new blood vessels from pre-existing vessels. Though there has been some debate over terminology, vasculogenesis is the term used for spontaneous blood-vessel formation, and intussusception is the term for the formation of new blood...
function – that is, it inhibits the growth of blood vessels. Because of this function, squalamine in its intravenous form, squalamine lactate, is in the process of being tested as a treatment of fibrodysplasia ossificans progressiva
Fibrodysplasia ossificans progressiva
Fibrodysplasia ossificans progressiva , sometimes referred to as Stone Man Syndrome, is an extremely rare disease of the connective tissue. A mutation of the body's repair mechanism causes fibrous tissue to be ossified when damaged. In many cases, injuries can cause joints to become permanently...
, a rare disease where connective tissue
Connective tissue
"Connective tissue" is a fibrous tissue. It is one of the four traditional classes of tissues . Connective Tissue is found throughout the body.In fact the whole framework of the skeleton and the different specialized connective tissues from the crown of the head to the toes determine the form of...
will ossify when damaged. Squalamine is also undergoing trials for treatment of non-small cell lung cancer
Lung cancer
Lung cancer is a disease characterized by uncontrolled cell growth in tissues of the lung. If left untreated, this growth can spread beyond the lung in a process called metastasis into nearby tissue and, eventually, into other parts of the body. Most cancers that start in lung, known as primary...
(stage I/IIA) as well as general phase I pharmacokinetic studies. In 2005, the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
granted squalamine Fast Track status for approval for treatment of age-related macular degeneration
Macular degeneration
Age-related macular degeneration is a medical condition which usually affects older adults and results in a loss of vision in the center of the visual field because of damage to the retina. It occurs in “dry” and “wet” forms. It is a major cause of blindness and visual impairment in older adults...
. However, the Genaera Corporation, the company that has done the most work with squalamine, discontinued trials for its use in treating prostate cancer
Prostate cancer
Prostate cancer is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostate cancers. The cancer cells may metastasize from the prostate to other parts of the body, particularly...
and wet age-related macular degeneration
Macular degeneration
Age-related macular degeneration is a medical condition which usually affects older adults and results in a loss of vision in the center of the visual field because of damage to the retina. It occurs in “dry” and “wet” forms. It is a major cause of blindness and visual impairment in older adults...
in 2007.
The Squalamine project was acquired by Ohr Pharmaceutical from the now liquidated Genaera, with the prospect of continuing the development of this drug to treat wet age-related macular degeneration
Macular degeneration
Age-related macular degeneration is a medical condition which usually affects older adults and results in a loss of vision in the center of the visual field because of damage to the retina. It occurs in “dry” and “wet” forms. It is a major cause of blindness and visual impairment in older adults...
.
A company (Nu-Gen Nutrition, Inc.) markets a product called 'Squalamax' as a dietary supplement
Dietary supplement
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...
, which it claims has concentrated Squalamine. The product has not been approved as a drug and cannot make therapeutic claims, as noted by the FDA in a Warning Letter
FDA Warning Letter
The United States Food and Drug Adminstration defines a Warning Letter as "...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations...
.
Sources
The most abundant source of squalamine is in the livers of dogfish and sharks, though it is found in other sources, such as lampreyLamprey
Lampreys are a family of jawless fish, whose adults are characterized by a toothed, funnel-like sucking mouth. Translated from an admixture of Latin and Greek, lamprey means stone lickers...
s. First synthesized in 1995, squalamine is usually artificially sourced.